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A phase 2, randomized, multicenter, double-blind, placebo-controlled trial of S-adenosyl methionine in participants with mild cognitive impairment or dementia due to Alzheimer's disease
Sarah Holper, Kevin J Barnham, Leonid Churilov, Paul Yates, Amy Brodtmann, Sally Johns, Qia-Xin Li, Oneil Bhalala et al.. Alzheimer's & dementia : the journal of the Alzheimer's Association, 2026-04
Topic: Drug trials: efficacy and safety
Mean percentage change in plasma p-tau217 in the SAMe group was an increase of 53.22 (standard deviation [SD] 159.19) compared to 25.34 (SD 94.83) in the placebo group (standardized mean difference 37.58, 95% confidence interval -32.61, 107.76; p = 0.288). No significant differences were observed in safety or other secondary endpoints. SAMe did not demonstrate disease-modifying efficacy at the dose and duration studied; however it was safe and well tolerated. TRIAL REGISTRATION: ACTRN12620000506998. Registered on the Australian New Zealand Clinical Trials Registry (http://www.anzctr.org.au).
Key findings
- Mean percentage change in plasma p-tau217 in the SAMe group was an increase of 53.22 (standard deviation [SD] 159.19) compared to 25.34 (SD 94.83) in the placebo group (standardized mean difference 37.58, 95% confidence interval -32.61, 107.76; p = 0.288).
- No significant differences were observed in safety or other secondary endpoints.
- SAMe did not demonstrate disease-modifying efficacy at the dose and duration studied; however it was safe and well tolerated.
- Registered on the Australian New Zealand Clinical Trials Registry (http://www.anzctr.org.au).
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Study details
- Study designclinical trial
- Participants63
- Evidence strengthHigh
How this study scored 85/100
Published in a leading specialty journal, and it is a randomised controlled trial. Scored zero for effect reported because the record does not state it. We have no data on journal's citation record, times cited, citations per year, impact for its field and year, cited by studies here, still being cited, senior author's track record, institution's track record and free to read, so those were left out: it earned 50 of the 59 points we could judge it on, which is 85 out of 100.
| Component | Points | Why |
|---|---|---|
| Journal tier | 9 / 10 | Tier 2 — leading specialty journal (Alzheimer's & dementia : the journal of the Alzheimer's Association) |
| Journal's citation record | — / 4 | No journal record from OpenAlex — left out of this score |
| Study design | 11 / 12 | A randomised controlled trial (from PubMed type “Randomized Controlled Trial”) |
| Strength of evidence | 5 / 5 | Rated “high” in our summary |
| Peer-review validation | 10 / 10 | Peer-reviewed. Published as an article in a named peer-reviewed journal. |
| How recent | 5 / 5 | 2026 — within 1 year(s) of the newest study here |
| Sample size | 1 / 4 | 63 participants |
| Effect reported | 0 / 3 | No effect size reported — scores zero (not stated in the record — scored 0) |
| Studied in people | 3 / 3 | Studied in people (participant count stated) |
| Randomised / blinded | 2 / 2 | Randomised and blinded or placebo-controlled (as stated in the record) |
| Times cited | — / 7 | No citation count (not found in OpenAlex) — left out of this score |
| Citations per year | — / 5 | No citation count or no year — left out of this score |
| Impact for its field and year | — / 6 | No field-weighted citation impact (OpenAlex has none yet) — left out of this score |
| Cited by studies here | — / 6 | Not yet checked against this library's citation graph — left out of this score |
| Still being cited | — / 4 | No yearly citation counts — left out of this score |
| Senior author's track record | — / 4 | Senior author's record not available — left out of this score |
| Institution's track record | — / 3 | No institution listed in OpenAlex — left out of this score |
| Multi-centre collaboration | 2 / 3 | PubMed indexes it as a multicentre study |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 41980907) |
| Free to read | — / 2 | Access not recorded — left out of this score |
| Points | 50 / 59 | Scored on 11 of 20 parts. We have no data for the rest, so they are left out: 50 of the 59 points we could judge it on is 85 out of 100. |
| Total | 85 / 100 | — |
What each of these 20 components measures, and what this score is not →
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APA 7th
Holper, S., Barnham, K. J., Churilov, L., Yates, P., Brodtmann, A., Johns, S., et al. (2026). A phase 2, randomized, multicenter, double-blind, placebo-controlled trial of S-adenosyl methionine in participants with mild cognitive impairment or dementia due to Alzheimer's disease. Alzheimer's & dementia : the journal of the Alzheimer's Association. https://doi.org/10.1002/alz.71381
Vancouver
Holper S, Barnham KJ, Churilov L, Yates P, Brodtmann A, Johns S, et al. A phase 2, randomized, multicenter, double-blind, placebo-controlled trial of S-adenosyl methionine in participants with mild cognitive impairment or dementia due to Alzheimer's disease. Alzheimer's & dementia : the journal of the Alzheimer's Association. 2026. doi:10.1002/alz.71381. PMID: 41980907.
BibTeX
@article{holper2026-41980907,
author = {Holper, Sarah and Barnham, Kevin J and Churilov, Leonid and Yates, Paul and Brodtmann, Amy and Johns, Sally and Li, Qia-Xin and Bhalala, Oneil and others},
title = {{A phase 2, randomized, multicenter, double-blind, placebo-controlled trial of S-adenosyl methionine in participants with mild cognitive impairment or dementia due to Alzheimer's disease}},
journal = {Alzheimer's \& dementia : the journal of the Alzheimer's Association},
year = {2026},
doi = {10.1002/alz.71381},
pmid = {41980907},
url = {https://doi.org/10.1002/alz.71381}
}